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Data updated: Mar 10, 2026

PHENOXYBENZAMINE HYDROCHLORIDE

PHENOXYBENZAMINE HYDROCHLORIDE
Cardiovascular Approved 2012-07-16
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
6
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2012-07-16
Routes
ORAL
Dosage Forms
CAPSULE

Companies

AMNEAL RISING Hikma NOVITIUM PHARMA PH HEALTH Aurobindo Pharma
Active Ingredient: PHENOXYBENZAMINE HYDROCHLORIDE

PHENOXYBENZAMINE HYDROCHLORIDE Approval History

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What PHENOXYBENZAMINE HYDROCHLORIDE Treats

2 indications

PHENOXYBENZAMINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pheochromocytoma
  • Hypertension
Source: FDA Label

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PHENOXYBENZAMINE HYDROCHLORIDE FDA Label Details

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Indications & Usage

Phenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta -blocking agent concomitantly.

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Data Sources

FDA Approval: ANDA212568 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.